Prospective Observational Epidemiologic Study of Maraviroc's Safety (POEM)
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ClinicalTrials.gov Identifier: NCT00665561 |
Recruitment Status
:
Active, not recruiting
First Posted
: April 24, 2008
Last Update Posted
: January 31, 2018
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Condition or disease | Intervention/treatment |
---|---|
Human Immunodeficiency Virus | Drug: Maraviroc along with an optimized background antiretroviral drug regimen Drug: Optimized background antiretroviral drug regimen without maraviroc |
Study Type : | Observational |
Actual Enrollment : | 2454 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-experienced Hiv-1 Infected Patients |
Actual Study Start Date : | March 31, 2008 |
Estimated Primary Completion Date : | February 26, 2019 |
Estimated Study Completion Date : | February 26, 2019 |

Group/Cohort | Intervention/treatment |
---|---|
Maraviroc exposed |
Drug: Maraviroc along with an optimized background antiretroviral drug regimen
Maraviroc prescribed per approved local label.
Other Name: Selzentry, Celsentri
|
Maraviroc unexposed |
Drug: Optimized background antiretroviral drug regimen without maraviroc
Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.
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- CDC Category C AIDS defining infections, Viral encephalitis, Rhabdomyolysis, Liver failure, Liver related deaths [ Time Frame: Followed till 6 months after drug discontinuation up to a total of 5 years. ]
- All Malignancies (AIDS defining and non-AIDS defining), Myocardial ischemia or infarction, All cause mortality [ Time Frame: Followed for a total of up to 5 years regardless of the time of drug discontinuaion. ]
- There are no Secondary Outcomes for this study. [ Time Frame: 0 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Treatment experienced, HIV-1 infected patients
- 18 years or older
- Receive an approved assay for determination of HIV-1 tropism
Exclusion Criteria:
- Pregnant or lactating
- Using CCR5 inhibitor other than maraviroc

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665561

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | ViiV Healthcare |
ClinicalTrials.gov Identifier: | NCT00665561 History of Changes |
Other Study ID Numbers: |
A4001067 2007-006148-24 ( EudraCT Number ) POEM ( Other Identifier: Alias Study Number ) |
First Posted: | April 24, 2008 Key Record Dates |
Last Update Posted: | January 31, 2018 |
Last Verified: | January 2018 |
Keywords provided by ViiV Healthcare:
Maraviroc HIV-1 Safety Non-interventional |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Slow Virus Diseases Maraviroc CCR5 Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |